A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: VIVUS LLC

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The study is being conducted to evaluate the effect of VI-0521 (Qsymia®) on blood pressure as measured by 24-hour ambulatory blood pressure monitoring, compared to both placebo and an active control (phentermine 30 mg).

Eligibility Criteria

Inclusion Criteria

Overweight/obese adult males/females 18-75 years of age with a BMI ≥ 27 kg/m2;

You are willing and able to wear ABPM monitor apparatus for 24 hours at beginning and end of study.

At least 1 weight-related comorbidity (i.e., hypertension, dyslipidemia, Type 2 diabetes mellitus [T2DM] or prediabetes, or obstructive sleep apnea).

Exclusion Criteria

Screening blood pressure of > 140/90 mmHg;

Type 1 diabetes; T2DM treated with SFUs, GLP-1 receptor agonists, SGLT inhibitors; or not on stable diabetic medications for at least 3 months prior to randomization;

History of glaucoma;

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Treatment Details

Interventions

Phentermine (Sympathomimetic agent)
Placebo (Other)
VI-0521 (Anti-obesity agent)

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)Experimental Treatment1 Intervention

Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily

Group II: Phentermine 30mgActive Control1 Intervention

Weeks 1-8: Phentermine 30mg oral capsule, once daily

Group III: PlaceboPlacebo Group1 Intervention

Weeks 1-8: Placebo oral capsule, once daily